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Propofol or Midazolam for Sedation and Early Extubation Following Coronary Artery Bypass Graft Surgery

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Midazolam
Sponsored by
Chaudhry Pervaiz Elahi Institute of Cardiology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring coronary artery bypass graft, midazolam, propofol

Eligibility Criteria

20 Years - 20 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients of American Society of Anesthesiologists (ASA) III who were selected for coronary artery bypass graft surgery.

Exclusion Criteria:

  • History of any psychiatric disease.
  • Using antidepressants
  • Alcohol abusers
  • Obese
  • Pregnant women

Sites / Locations

  • Ch. Pervaiz Elahi Institute of Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MIdazolam Group

Propofol Group

Arm Description

Following surgery Immediately after shifting in ICU, midazolam infusion were administered as 0.25 mg/kg/min.

Following surgery after Immediately shifting in ICU propofol infusion was started at 10µg/kg/min.

Outcomes

Primary Outcome Measures

Duration of post-surgery sedation
Duration of post-surgery sedation following cardiac surgery
Time taken to post-surgery extubation
Time taken from the end of cardiac surgery to post-surgery extubation

Secondary Outcome Measures

Full Information

First Posted
January 30, 2022
Last Updated
March 11, 2022
Sponsor
Chaudhry Pervaiz Elahi Institute of Cardiology
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1. Study Identification

Unique Protocol Identification Number
NCT05290324
Brief Title
Propofol or Midazolam for Sedation and Early Extubation Following Coronary Artery Bypass Graft Surgery
Official Title
Propofol or Midazolam for Sedation and Early Extubation Following Coronary Artery Bypass Graft Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
February 1, 2020 (Actual)
Study Completion Date
February 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chaudhry Pervaiz Elahi Institute of Cardiology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Propofol and midazolam are used frequently as sedating agents among patients who undergo coronary artery bypass graft surgery but no study in Pakistan has been done to compare their effectiveness aiming early extubation.
Detailed Description
Propofol is an intra lipid and alkali phenol chemically it is unrelated to sedative agents or anaesthetic. Midazolam is a banzodiazepen. Most of its properties are similar to diazepam. It is a common practice to use sedatives to provide comfort and decrease "ventilator-asynchrony" in critically ill patients that may require prolonged invasive mechanical ventilation. The other reason to employ sedatives is to reduce the anxiety associated with the inaviseve procedures routinely conducted in the ICU.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
coronary artery bypass graft, midazolam, propofol

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Radomized Controlled Trial
Masking
Participant
Masking Description
Open label
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIdazolam Group
Arm Type
Experimental
Arm Description
Following surgery Immediately after shifting in ICU, midazolam infusion were administered as 0.25 mg/kg/min.
Arm Title
Propofol Group
Arm Type
No Intervention
Arm Description
Following surgery after Immediately shifting in ICU propofol infusion was started at 10µg/kg/min.
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Versed
Intervention Description
Midazolam infusion will be given after the surgery as 0.25 mg/kg/min.
Primary Outcome Measure Information:
Title
Duration of post-surgery sedation
Description
Duration of post-surgery sedation following cardiac surgery
Time Frame
Time in minutes calculated from end of surgery to the time of awakening up to 24 hours in both study groups
Title
Time taken to post-surgery extubation
Description
Time taken from the end of cardiac surgery to post-surgery extubation
Time Frame
Time taken in minutes from the end of the cardiac surgery to post-surgery extubation up to 1 week duration in both study groups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients of American Society of Anesthesiologists (ASA) III who were selected for coronary artery bypass graft surgery. Exclusion Criteria: History of any psychiatric disease. Using antidepressants Alcohol abusers Obese Pregnant women
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shumaila Rai, MBBS
Organizational Affiliation
Ch. Pervaiz Elahi Institute of Cardiology, Multan, Pakisan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ch. Pervaiz Elahi Institute of Cardiology
City
Multan
State/Province
Punjab
ZIP/Postal Code
59341
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Propofol or Midazolam for Sedation and Early Extubation Following Coronary Artery Bypass Graft Surgery

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